A Study to Learn About the Study Medicine Called PF-07258669 in Older Adults Including Those at Risk of Malnutrition

NCT ID: NCT07086664

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-05

Study Completion Date

2026-01-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to look at safety, tolerability, and pharmacodynamic effects (i.e. how the study drug affects your body) of PF-07258669 in older participants ((60 years to \<90 years) including those at risk of malnutrition.

The study medicine PF-07258669 is being developed for the treatment of unintended weight loss in older adults. People with this condition have decreased appetite and food intake, which is an important reason for poor nutrition and health results in people with unintended weight loss.

This is approximately a 26-week-long study with 9 visits to the study doctor and 4 telehealth visits (ie. visits by phone call). The study will include

* Screening period for up to 4 weeks
* Pre-treatment period of 2 weeks
* Treatment period of 16 weeks : study drug (PF-07258669 or matching placebo)
* Follow-up period of 4 weeks The study requires answering questionnaires and use of digital devices at home to measure blood pressure and physical activity. The study team will monitor how each participant is doing during the study

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral tablet

PF-07258669

Group Type EXPERIMENTAL

PF-07258669

Intervention Type DRUG

Oral tablet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

Oral tablet

Intervention Type DRUG

PF-07258669

Oral tablet

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Voluntary diet restriction or eating disorder
Minimum Eligible Age

60 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Accel Research Sites - Birmingham Clinical Research Unit

Birmingham, Alabama, United States

Site Status

JEM Research Institute

Atlantis, Florida, United States

Site Status

Bradenton Research Center, Inc.

Bradenton, Florida, United States

Site Status

McKnight Brain Institute

Gainesville, Florida, United States

Site Status

De La Cruz Research Center, LLC

Miami, Florida, United States

Site Status

Renstar Medical Research

Ocala, Florida, United States

Site Status

Headlands Research Orlando

Orlando, Florida, United States

Site Status

Shields MRI Brockton

Brockton, Massachusetts, United States

Site Status

Headlands Eastern MA LLC

Plymouth, Massachusetts, United States

Site Status

AA Medical Research Center

Flint, Michigan, United States

Site Status

Clinical Research Professionals

Chesterfield, Missouri, United States

Site Status

Javara - Nevada Health Centers - Carson City

Carson City, Nevada, United States

Site Status

Circuit Clinical

Secaucus, New Jersey, United States

Site Status

Circuit Clinical /North Hudson Community Action Corporation

West New York, New Jersey, United States

Site Status

OCT Research ULC

Kelowna, British Columbia, Canada

Site Status

Alpha Recherche Clinique - Lévis

Lévis, Quebec, Canada

Site Status

Diex Recherche Trois-Rivieres

Trois-Rivières, Quebec, Canada

Site Status

Diex Recherche Inc. Division Victoriaville

Victoriaville, Quebec, Canada

Site Status

Centre de Recherche Saint-Louis inc.

Québec, , Canada

Site Status

ALPHA Recherche Clinique

Québec, , Canada

Site Status

Shonan Fujisawa Tokushukai Hospital

Fujisawa, Kanagawa, Japan

Site Status

Yao Tokushukai General Hospital

Yao Shi, Osaka, Japan

Site Status

Juntendo Tokyo Koto Geriatric Medical Center

Koto-ku, Tokyo, Japan

Site Status

Yamagata Tokushukai Hospital

Yamagata, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada Japan

Related Links

Access external resources that provide additional context or updates about the study.

https://pmiform.com/clinical-trial-info-request?StudyID=C4541011

To obtain contact information for a study center near you, click here.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2025-520763-41-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

C4541011

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

ONO-7746 Study in Healthy Adult Subject
NCT01106664 COMPLETED PHASE1